Verastem(US:VSTM)2023-11-08 21:16Financial Performance - The company has an accumulated deficit of $797.5 million as of September 30, 2023[151]. - The net loss for the three months ended September 30, 2023, was $20.0 million, compared to $60.0 million for the same period in 2022[151]. - Total revenue for the nine months ended September 30, 2023 was $0.0 million, a decrease of 100% from $2.6 million in the same period of 2022[168]. - Net loss for Q3 2023 was $20.0 million, an increase of 11% compared to a net loss of $18.1 million in Q3 2022[157]. - Research and development expenses for Q3 2023 were $13.9 million, an increase of 24% from $11.3 million in Q3 2022[157]. - Total operating expenses for Q3 2023 were $21.3 million, up 20% from $17.7 million in Q3 2022[157]. - Research and development expenses for the nine months ended September 30, 2023 were $38.9 million, a slight decrease of 2% from $39.8 million in the same period of 2022[169]. - Selling, general and administrative expenses for the nine months ended September 30, 2023 were $22.1 million, an increase of 17% from $18.9 million in the same period of 2022[168]. - Selling, general and administrative expenses increased to $22.1 million in 2023 from $18.9 million in 2022, a rise of 16.9%[174]. - Interest income for Q3 2023 was $2.2 million, a significant increase of 611% from $0.3 million in Q3 2022[165]. - Interest expense for Q3 2023 was $1.1 million, up 57% from $0.7 million in Q3 2022[166]. - Interest income surged to $4.3 million in 2023, up from $0.4 million in 2022, reflecting a significant increase of 975% driven by higher interest rates and investment balances[176]. - Interest expense rose to $3.0 million in 2023 compared to $1.4 million in 2022, marking an increase of 114.3% primarily due to a loan agreement with Oxford[177]. - Net cash used in operating activities was $56.8 million for the 2023 period, compared to $47.1 million in 2022, indicating a 20.4% increase in cash outflow[182]. - Cash provided by financing activities in 2023 was $134.6 million, significantly higher than $51.8 million in 2022, reflecting a 159.5% increase[184]. - The company expects existing cash resources to fund planned operations for at least 12 months from the date of the financial statements[151]. - The company is exposed to interest rate risk, with a total of $165.7 million in cash and investments as of September 30, 2023, which could be affected by changes in U.S. interest rates[191]. - As of September 30, 2023, the company had $165.7 million in cash, cash equivalents, and investments[181]. Clinical Trials and Research - The combination of avutometinib and defactinib demonstrated an overall objective response rate (ORR) of 45% in patients with recurrent low-grade serous ovarian cancer (LGSOC) in the RAMP 201 trial[142]. - Among patients with KRAS mutant LGSOC, the ORR was 60%, while it was 29% for KRAS wild-type LGSOC[143]. - The FRAME study showed an ORR of 42% in evaluable patients with LGSOC, with a median duration of response of 26.9 months[144]. - The company plans to initiate a confirmatory Phase 3 trial (RAMP 301) to evaluate the efficacy and safety of the combination therapy in recurrent LGSOC in the second half of 2023[145]. - The RAMP 203 trial, evaluating the combination of avutometinib with Amgen's KRAS G12C inhibitor, has shown a confirmed ORR of 25% across efficacy-evaluable patients[146]. - The company received a grant of up to $3.8 million from the Pancreatic Cancer Network to support the RAMP 205 trial, which will evaluate the combination of avutometinib and defactinib in pancreatic cancer[148]. Strategic Partnerships - The company entered into a collaboration agreement with GenFleet Therapeutics, involving an upfront payment of $2.0 million and potential milestone payments of up to $622.0 million[186][187]. - The company expects to finance operations through future potential milestones and royalties from the Secura APA[180]. - The company may terminate the GenFleet Agreement with 90 days written notice, allowing flexibility in its strategic partnerships[188]. - The company made a $2.0 million upfront payment in September 2023 under the GenFleet Agreement, contributing to increased R&D costs[162].